Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01343056
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2011-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Program Reinforcement Impacts Self Management (PRISM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'simineriol@upmc.edu', 'phone': '412-864-0158', 'title': 'Linda Siminerio, PhD', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Office Staff Follow up of Diabetes Education', 'description': 'A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Peer Follow up of Diabetes Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin A1C (HbA1C, %)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Office Staff Follow up of Diabetes Education', 'description': 'A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG001', 'title': 'Peer Follow up of Diabetes Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '9.6'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '11.6'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '8.8'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '5.9', 'upperLimit': '10.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of glycosolated hemoglobin', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Office Staff Follow up Education', 'description': 'A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nOffice Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education.'}, {'id': 'OG001', 'title': 'Peer Follow up Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nPeer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nUsual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management.'}, {'id': 'OG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.\n\nEducator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered.'}], 'classes': [{'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '205'}, {'value': '159', 'groupId': 'OG001', 'lowerLimit': '121', 'upperLimit': '369'}, {'value': '175', 'groupId': 'OG002', 'lowerLimit': '129', 'upperLimit': '321'}, {'value': '150', 'groupId': 'OG003', 'lowerLimit': '27', 'upperLimit': '210'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.'}, {'type': 'SECONDARY', 'title': 'High Density Lipoprotein (HDL, mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Office Staff Follow up of Diabetes Education', 'description': 'A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG001', 'title': 'Peer Follow up of Diabetes Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '70'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '67'}, {'value': '39', 'groupId': 'OG002', 'lowerLimit': '32', 'upperLimit': '53'}, {'value': '39', 'groupId': 'OG003', 'lowerLimit': '23', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.'}, {'type': 'SECONDARY', 'title': 'Low Density Lipoprotein (LDL, mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Office Staff Follow up of Diabetes Education', 'description': 'A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG001', 'title': 'Peer Follow up of Diabetes Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '139'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '274'}, {'value': '103', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '203'}, {'value': '39', 'groupId': 'OG003', 'lowerLimit': '23', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Office Staff Follow up of Diabetes Education', 'description': 'A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG001', 'title': 'Peer Follow up of Diabetes Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '.7', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '.9', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The DES-SF is a validated, 8 item scale that measures the self-efficacy of patients with diabetes. Responses are selected from a 5-point Likert scale (Strongly Disagree (1), Somewhat Disagree (2), Neutral (3), Somewhat Agree (4), Strongly Agree (5)). The scale is scored by averaging the scores of all completed items (sum of scores divided by 8).\n\nA positive number represents an improvement in overall patient self-efficacy (empowerment) from the baseline score and 6 month follow up time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Office Staff Follow up Education', 'description': 'A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nOffice Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education.'}, {'id': 'OG001', 'title': 'Peer Follow up Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nPeer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nUsual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management.'}, {'id': 'OG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.\n\nEducator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000', 'lowerLimit': '23.5', 'upperLimit': '57'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '23.2', 'upperLimit': '47.1'}, {'value': '32.3', 'groupId': 'OG002', 'lowerLimit': '23.8', 'upperLimit': '48'}, {'value': '33.9', 'groupId': 'OG003', 'lowerLimit': '24.9', 'upperLimit': '50.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': "Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight.", 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Office Staff Follow up of Diabetes Education', 'description': 'A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG001', 'title': 'Peer Follow up of Diabetes Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'OG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '109'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '92'}, {'value': '78', 'groupId': 'OG002', 'lowerLimit': '58', 'upperLimit': '90'}, {'value': '75', 'groupId': 'OG003', 'lowerLimit': '60', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Diastolic blood pressure is the pressure when the heart is at rest between beats.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Office Staff Follow up Education', 'description': 'A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nOffice Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education.'}, {'id': 'OG001', 'title': 'Peer Follow up Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nPeer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nUsual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management.'}, {'id': 'OG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.\n\nEducator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered.'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '155'}, {'value': '130', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': '156'}, {'value': '132', 'groupId': 'OG002', 'lowerLimit': '102', 'upperLimit': '150'}, {'value': '132', 'groupId': 'OG003', 'lowerLimit': '110', 'upperLimit': '158'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Systolic blood pressure is the pressure when the heart beats while pumping blood.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Office Staff Follow up of Diabetes Education', 'description': 'A designee in the office shall be assigned to follow up with the patient for goal attainment. It was suggested that they phone the participant monthly. Staff also received training on how best to provide support to patients.'}, {'id': 'FG001', 'title': 'Peer Follow up of Diabetes Education', 'description': 'A person with diabetes trained as a "peer" met with the participant at their 6 week follow up visit and then called the participant monthly to monitor goal attainment.'}, {'id': 'FG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call was made by a diabetes educator.'}, {'id': 'FG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator provided support to patients with periodic phone calls. Diabetes educators received training in ways to improve patient empowerment and best support their patients following diabetes education.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Office Staff Follow up of Diabetes Education', 'description': 'A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'BG001', 'title': 'Peer Follow up of Diabetes Education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'BG002', 'title': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'BG003', 'title': 'Educator Support Follow up', 'description': 'A diabetes educator will provide follow up support.\n\nFour different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '64', 'spread': '10', 'groupId': 'BG001'}, {'value': '60', 'spread': '12', 'groupId': 'BG002'}, {'value': '60', 'spread': '10', 'groupId': 'BG003'}, {'value': '60', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'recruited type 2 diabetes patients who were referred for diabetes education'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2011-04-19', 'resultsFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-06', 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1C (HbA1C, %)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Total Cholesterol (mg/dL)', 'timeFrame': '6 months'}, {'measure': 'High Density Lipoprotein (HDL, mg/dL)', 'timeFrame': '6 months'}, {'measure': 'Low Density Lipoprotein (LDL, mg/dL)', 'timeFrame': '6 months'}, {'measure': 'Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores', 'timeFrame': '6 months', 'description': 'The DES-SF is a validated, 8 item scale that measures the self-efficacy of patients with diabetes. Responses are selected from a 5-point Likert scale (Strongly Disagree (1), Somewhat Disagree (2), Neutral (3), Somewhat Agree (4), Strongly Agree (5)). The scale is scored by averaging the scores of all completed items (sum of scores divided by 8).\n\nA positive number represents an improvement in overall patient self-efficacy (empowerment) from the baseline score and 6 month follow up time point.'}, {'measure': 'Body Mass Index', 'timeFrame': '6 months', 'description': "Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight."}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '6 months', 'description': 'Diastolic blood pressure is the pressure when the heart is at rest between beats.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '6 months', 'description': 'Systolic blood pressure is the pressure when the heart beats while pumping blood.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Self Management Education (DSME)', 'Diabetes', 'Self Management Support (SMS)'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23782622', 'type': 'BACKGROUND', 'citation': 'Siminerio L, Ruppert KM, Gabbay RA. Who can provide diabetes self-management support in primary care? Findings from a randomized controlled trial. Diabetes Educ. 2013 Sep-Oct;39(5):705-13. doi: 10.1177/0145721713492570. Epub 2013 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'Patients who receive DSME (Diabetes Self Management Education) will be enrolled in a 4 arm, randomized study with each group receiving a different method of follow up. The 4 arms will be evaluated based on clinical indicators, goal achievement and patient satisfaction.', 'detailedDescription': 'As the diabetes burden worsens, the need for people to become more involved in self-management will increase. Research has demonstrated that diabetes self-management education (DSME) can improve HbA1C levels by 0.76%. While the rates of diabetes are increasing, the numbers of educators available are shrinking. This is a particular hardship in underserved and military communities where the supply of health care providers is already scarce. Our investigative team has led efforts in supporting DSME in the PA state-wide deployment of the Chronic Care Model (CCM) and reported findings nationally on innovative ways to increase the pool of education services by integrating educators into primary care, establishing nurse clinics in underserved communities and demonstrating that an educator position could be sustained by reimbursement. A 0.76% reduction associated to DSME can be considered an enormous benefit and is equivalent to the impact of most pharmacologic treatments for diabetes. Unfortunately, however the benefits of DSME decrease over time. This suggests that sustained improvements require contact and follow-up. SMS is defined as the process of ongoing support of patient self-care, to sustain the gains following DSME. There is often confusion among the terms self-management education (DSME) and self-management support (SMS). DSME is associated with the provision of knowledge and skills training delivered by a health care professional, e.g. nurses, dietitians, etc. SMS is defined as the process of making and refining changes in health care systems (and the community) to support patient self-care and maintain the gains made following DSME. We know that SMS is currently provided by diabetes educators, but only one 3-6 month follow up is usual care. It has been suggested that SMS can be provided by community workers, peers with diabetes, and office staff within community sites, like PCP offices, and wellness centers, etc. The National Standards for DSME and American Diabetes Association (ADA) Education Recognition Program (ERP) require that SMS approaches be delivered and documented, yet no evidence has been provided to define who should deliver it and how often. This uncertainty has led to many programs delivering SMS in an unstructured, non-standardized and at times haphazard fashion. Practical approaches designed for providing SMS have the potential to sustain improvements. The objective of this study is to compare Self-Management Support (SMS) interventions following Diabetes Self-Management Education (DSME) and determine which will be more likely to maintain improvements in behavioral and clinical outcomes following DSME while achieving patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A person with diabetes referred for diabetes education\n\nExclusion Criteria:\n\n* Gestational diabetes and pregnancy\n* If a person has recently had diabetes education, they will not be enrolled in the study'}, 'identificationModule': {'nctId': 'NCT01343056', 'acronym': 'PRISM', 'briefTitle': 'Program Reinforcement Impacts Self Management (PRISM)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Program Reinforcement Impacts Self Management', 'orgStudyIdInfo': {'id': 'PRO10090392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Office Staff follow up education', 'description': 'A designee in the office staff shall be assigned to follow up with the patient for for behavioral goal setting attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.\n\nThe intervention is the follow up goal attainment and office staff have been trained on elements of goal attainment.', 'interventionNames': ['Behavioral: Office Staff Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Peer follow up education', 'description': 'A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor behavioral goal attainment.The intervention is the follow up goal attainment and peers have been trained on elements of goal attainment.', 'interventionNames': ['Behavioral: Peer Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator. The intervention is the diabetes educator making a phone call to the patient to ask how they are doing.', 'interventionNames': ['Behavioral: Usual Care Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educator support follow up', 'description': 'A diabetes educator will provide follow up support and make monthly call to the patient to ascertain behavioral goal setting attainment. The diabetes educator uses behavioral goal setting as an education intervention. The educator calls patient to determine goal attainment. That is the intervention.', 'interventionNames': ['Behavioral: Educator Support']}], 'interventions': [{'name': 'Office Staff Support', 'type': 'BEHAVIORAL', 'description': 'The intervention includes the Office staff of primary care practices trained to provide diabetes support for behavioral goal setting were tasked to follow up with patients via phone following completion of diabetes self-management education.', 'armGroupLabels': ['Office Staff follow up education']}, {'name': 'Peer Support', 'type': 'BEHAVIORAL', 'description': 'Community peers trained to provide diabetes support for behavioral goal setting were tasked to follow up with patients via phone following completion of diabetes self-management education.', 'armGroupLabels': ['Peer follow up education']}, {'name': 'Usual Care Support', 'type': 'BEHAVIORAL', 'description': 'Diabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management.', 'armGroupLabels': ['Usual Care']}, {'name': 'Educator Support', 'type': 'BEHAVIORAL', 'description': 'Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.', 'armGroupLabels': ['Educator support follow up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Linda Siminerio, RN, PhD, CDE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Robert Gabbay, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Penn State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Linda Siminerio, RN, PhD, CDE, Executive Director', 'investigatorFullName': 'Linda Siminerio', 'investigatorAffiliation': 'University of Pittsburgh'}}}}